DJO Aircast Cyro/Cuff IC Mode D'emploi page 13

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Immunity Tests
Cryo Cuff IC is intended for use in the electromagnetic environment specified below. The customer or the
user of Cryo Cuff IC should assure that it is used in such an environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which Cryo Cuff IC is used exceeds the applicable RF compliance level above, Cryo Cuff
IC should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Cold Therapy Unit.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
ELECTROMAGNETIC COMPATIBILITY (EMC)
IEC 60601 Compliance
Test Level Level
3 Vrms 3 V
150 kHz to
80 MHz
3 V/m 3 V/m
80 MHz to
2.5 GHz
Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Cold Therapy Unit, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = [3.5/V ]√P 150 KHz to 80 MHz
1
d = [3.5/E ]√P 80 MHz to 800 MHz
1
d = [7/E ]√P 800 MHz to 2.5 GHz
1
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of
equipment marked with the following symbol:
11
.
b
] V/m.
1
EN
,
a